Welcome to our dedicated page for Jazz Pharmaceuticals Plc news (Ticker: JAZZ), a resource for investors and traders seeking the latest updates and insights on Jazz Pharmaceuticals Plc stock.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) generates frequent news across neuroscience and oncology, reflecting its focus on serious diseases such as sleep disorders, rare epilepsies, HER2-driven cancers and aggressive brain tumors. This news page aggregates company press releases and third-party coverage so readers can follow how Jazz’s clinical programs, marketed medicines and corporate actions evolve over time.
Visitors can expect updates on clinical trial results and data presentations for products like Epidiolex/Epidyolex (cannabidiol), Xywav (low-sodium oxybate), Ziihera (zanidatamab-hrii) and Modeyso (dordaviprone). Jazz regularly announces new Phase 3 and Phase 4 findings, real-world evidence analyses, and translational research presented at major meetings such as the European Epilepsy Congress, American Epilepsy Society Annual Meeting, World Sleep Congress, ASCO Gastrointestinal Cancers Symposium and the Society for Neuro-Oncology Annual Meeting.
News items also cover regulatory milestones, such as indications granted by the U.S. Food and Drug Administration and other health authorities, as well as designations like Breakthrough Therapy, Fast Track and Orphan Drug status for certain oncology assets. Corporate announcements may include executive appointments, board changes, investor webcasts, participation in healthcare conferences and legal or settlement updates disclosed in tandem with SEC filings.
For investors, clinicians and patients researching JAZZ, this page offers a centralized view of how Jazz Pharmaceuticals communicates progress in sleep medicine, epilepsy, oncology and neuro-oncology. By reviewing the news feed over time, readers can see how key programs advance from early data readouts through larger trials, regulatory interactions and post-approval evidence generation.
Jazz Pharmaceuticals (Nasdaq: JAZZ) reported 3Q25 total revenues of $1.126B, up 7% year‑over‑year, driven by Xywav, Epidiolex and the Modeyso launch. Modeyso received FDA accelerated approval and generated $11.0M in 3Q25 after an August launch. Xywav sales were $431.4M (+11%) and Epidiolex was $302.6M (+20%). GAAP net income for 3Q25 was $251.4M and non‑GAAP adjusted net income was $500.7M. Cash and investments were $2.0B with long‑term debt of $5.4B. Company narrowed 2025 revenue guidance to $4,175–$4,275M and provided updated GAAP and non‑GAAP guidance.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced that Ted W. Love, M.D. will join the Board of Directors effective December 1, 2025. Dr. Love brings 30+ years of drug development and global commercialization experience, including leadership roles at Global Blood Therapeutics (CEO until its 2023 acquisition by Pfizer), Onyx, Nuvelo, and Genentech.
The appointment supports Jazz's stated board renewal effort—six directors have been appointed in the past five years—and coincides with the planned retirement of long-tenured director Kenneth O'Keefe, effective December 1, 2025.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will report its 2025 third quarter financial results on Wednesday, November 5, 2025 after the U.S. market close. Management will host a live audio webcast at 4:30 p.m. EST / 9:30 p.m. GMT to discuss the results and provide a business and financial update.
Participants may register in advance via the Investors section of the Jazz Pharmaceuticals website and are recommended to register at least 15 minutes before the webcast. A replay will be available in the Investors events and presentations area.
Jazz Pharmaceuticals is a global biopharma company focused on therapies for sleep disorders, epilepsy, and oncology, headquartered in Dublin with global R&D and manufacturing operations.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced FDA approval on Oct 2, 2025 of Zepzelca (lurbinectedin) plus atezolizumab (or atezolizumab/hyaluronidase-tqjs) as the first-line maintenance therapy for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after induction with atezolizumab, carboplatin and etoposide.
The approval is based on Phase 3 IMforte results showing a 46% reduction in risk of progression or death and a 27% reduction in risk of death; median OS 13.2 vs 10.6 months (HR=0.73; p=0.0174) and median PFS 5.4 vs 2.1 months (HR=0.54; p<0.0001). The regimen was added to NCCN SCLC guidelines as a preferred maintenance option. Common adverse reactions (≥30%) include cytopenias, nausea, and fatigue.
Jazz Pharmaceuticals (NASDAQ: JAZZ) presented significant Phase 4 data and real-world evidence for Xywav® at World Sleep 2025 and Psych Congress 2025. The key findings from the DUET trial demonstrated positive treatment effects of low-sodium Xywav on both daytime and nighttime symptoms in adults with narcolepsy or idiopathic hypersomnia (IH).
Notable results include improved sleep measures with fewer awakenings in narcolepsy patients, reduced sleep inertia in IH patients, and positive outcomes for patients taking 9-12 gram doses. Real-world analysis revealed that individuals with narcolepsy or IH have an elevated risk of cardiovascular, cardiometabolic and renal complications, emphasizing the importance of low-sodium treatment options.
Jazz Pharmaceuticals (NASDAQ: JAZZ) announced that Modeyso™ (dordaviprone) has been included in the NCCN Clinical Practice Guidelines as a category 2A treatment option for H3 K27M-mutant diffuse glioma. This follows the FDA's accelerated approval on August 6, 2025 for treating adult and pediatric patients with diffuse midline glioma.
Clinical trials demonstrated an overall response rate of 22% among 50 patients, with a median response duration of 10.3 months. Among responders, 73% maintained response for at least six months. Safety evaluation in 376 patients showed serious adverse reactions in 33% of cases, with common side effects including fatigue, headache, and vomiting.
Modeyso represents the first treatment option for this ultra-rare and aggressive brain tumor, marking a significant advancement in patient care.
Jazz Pharmaceuticals (NASDAQ:JAZZ) announced its participation in the upcoming 2025 Wells Fargo Healthcare Conference. Company management will conduct a fireside chat on September 3, 2025, at 6:30 a.m. PDT.
The presentation will be accessible through a live audio webcast on the company's investor relations website, with replays available for 30 days. Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for sleep disorders, epilepsy, and cancer treatments.
Jazz Pharmaceuticals (NASDAQ: JAZZ) will host an investor webcast on August 27, 2025, at 4:30 p.m. EDT to discuss Modeyso™ (dordaviprone), their newly approved treatment for diffuse midline glioma. The presentation will feature insights from Jazz's senior management and Dr. Timothy Cloughesy, distinguished professor from UCLA Brain Tumor Center.
Notably, Modeyso received FDA accelerated approval on August 6, 2025, becoming the first and only approved treatment for patients aged 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease after prior therapy. The webcast will cover clinical data, patient needs, and commercialization strategy for this breakthrough treatment.
Jazz Pharmaceuticals (Nasdaq: JAZZ) has entered into a global licensing agreement with Saniona (Nasdaq OMX: SANION) for exclusive worldwide rights to develop and commercialize SAN2355, a preclinical asset for epilepsy treatment. Jazz will pay $42.5 million upfront to Saniona.
The agreement includes potential payments of up to $192.5 million in development and regulatory milestones, including $7.5 million for Phase 1 initiation, up to $800 million in commercial milestones, and tiered royalties from mid-single digits to low-double digits on net sales.
SAN2355 is a subtype-selective Kv7.2/Kv7.3 activator designed to overcome limitations of non-selective Kv7-targeting compounds. Jazz will lead and fund development, regulatory submissions, and global commercialization efforts.
Jazz Pharmaceuticals (NASDAQ: JAZZ) has achieved a groundbreaking milestone with the FDA's accelerated approval of Modeyso™ (dordaviprone), the first-ever treatment for H3 K27M-mutant diffuse midline glioma with progressive disease. This ultra-rare and aggressive brain tumor affects approximately 2,000 people annually in the U.S., primarily children and young adults.
The approval is based on clinical studies showing an overall response rate of 22% among 50 patients, with a median response duration of 10.3 months. Among responders, 73% maintained their response for at least six months. The safety evaluation, conducted across 376 patients, revealed serious adverse reactions in 33% of cases.
Modeyso, administered as a weekly oral capsule, will be commercially available in the coming weeks. Continued approval may depend on results from the Phase 3 ACTION confirmatory trial.